ASCENSIA DIABETES CARE US INC.

Address:5 Wood Hollow Road,Parsippany,NJ,07054,US

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Test, Blood Glucose, Over The Counter (NBW) (5) Glucose Dehydrogenase, Glucose (LFR) (3) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (3) Artificial Pancreas Device System, Single Hormonal Control (OZP) (2) Lancet, Blood (FMK) (2) Artificial Pancreas Device System, Threshold Suspend (OZO) (2) Calculator/Data Processing Module, For Clinical Use (JQP) (1)

Premarket Exempt

No Yes

Clear

GLUCOFACTS® DELUXE - 00301933515013 Catalog Number : 3515

Device Description : Diabetes Management Software

Device Class : 1

Duns Number: 080028910

Premarket Exempt : No

Product Code : JQP

Prescription Use : Yes

Device Count : 1

CONTOUR® DIABETES APP - 00301933536018 Catalog Number : 85498770

Device Description : Diabetes Management Software

Device Class : 2

Duns Number: 080028910

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

CONTOUR® DIABETES APP - 00301933537015 Catalog Number : 85498754

Device Description : Diabetes Management Software

Device Class : 2

Duns Number: 080028910

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

CONTOUR® NEXT LINK - 00301936201012 Catalog Number : 6201

Device Description : Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the followin

Device Class : 1

Duns Number: 080028910

Premarket Exempt : No

Product Code : JJX, LFR, NBW

Prescription Use : Yes

Device Count : 1

CONTOUR® NEXT LINK - 00301936203016 Catalog Number : 6203

Device Description : Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the followin

Device Class : 1

Duns Number: 080028910

Premarket Exempt : No

Product Code : JJX, LFR, NBW

Prescription Use : Yes

Device Count : 1

CONTOUR® NEXT LINK - 00301936207014 Catalog Number : 6207

Device Description : Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the followin

Device Class : 1

Duns Number: 080028910

Premarket Exempt : No

Product Code : JJX, LFR, NBW

Prescription Use : Yes

Device Count : 1

CONTOUR® NEXT LINK 2.4 - 00301936260019 Catalog Number : 6260

Device Description : Wireless Blood Glucose Monitoring System. 1 Kit.For Self-testing of Diabetes. Ki

Device Class : 3

Duns Number: 080028910

Premarket Exempt : No

Product Code : OZO, OZP

Prescription Use : Yes

Device Count : 1

CONTOUR® NEXT LINK 2.4 - 00301936262013 Catalog Number : 6262

Device Description : Wireless Blood Glucose Monitoring System. 1 Kit.For Self-testing of Diabetes. Ki

Device Class : 3

Duns Number: 080028910

Premarket Exempt : No

Product Code : OZO, OZP

Prescription Use : Yes

Device Count : 1

MICROLET® - 00301936586218 Catalog Number : 81264857, 81264954 (US)

Device Description : Colored lancets. Silicone-coated lancets. Use with the MICROLET Family of lanc

Device Class :

Duns Number: 080028910

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

MICROLET®NEXT - 00301936702014 Catalog Number : 85139940

Device Description : Lancing Device. 1 Kit: 1 MICROLET®NEXT lancing device with adjustable endcap; 5

Device Class : 2

Duns Number: 080028910

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

Previous 1 2 3 4 5 … 9 Next